Vivo 45 LS
K-Number: K232365 · 2025-12-19
Decision Date2025-12-19
Product CodeCBK
Advisory CommitteeAN
DecisionSubstantially Equivalent
Device Summary
Vivo 45 LS is a medical device manufactured by Oconnell Regulatory Consultants, Inc.. It received FDA 510(k) clearance on 2025-12-19 under approval number K232365. The device is classified under product code CBK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Vivo 45 LS?
Vivo 45 LS is a medical device that received FDA 510(k) clearance on 2025-12-19. It is manufactured by Oconnell Regulatory Consultants, Inc.. The 510(k) number is K232365.
When was Vivo 45 LS approved by the FDA?
Vivo 45 LS received FDA 510(k) clearance on 2025-12-19, under approval number K232365.
What company makes Vivo 45 LS?
Vivo 45 LS is manufactured by Oconnell Regulatory Consultants, Inc..
What is the FDA product code for Vivo 45 LS?
The FDA product code for Vivo 45 LS is CBK.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.